Self- Versus Conventional-swabbing for COVID-19 Screening (COVISWAB) (COVISWAB)
2 avril 2021 mis à jour par: University Hospital, Clermont-Ferrand
Comparison for Sensitivity and Tolerance of Self-swabbing and Conventional Nasopharyngeal Swabbing for SARS-CoV-2 Detection for Pain, Discomfort and Acceptability: a Randomized Controlled Non-inferiority Study
Self-swabbing requires less personal protective equipment and could allow to test more people and even to do quick self-diagnosis if antigenic tests are available.
In a preliminary study on 190 medical students, the investigators have shown that self and conventional swabbing were identically well-accepted with equivalent level of pain and discomfort induced by swabbing. In a sub-group of this sample, the investigators have shown that the quality of the 2 sampling methods were equivalent.
The goal of this large study in the general population is to confirm these findings in an adequately powered study. Such results would allow to develop self-swabbing for large screening campaigns and eventually self-diagnosis using antigenic tests.
Aperçu de l'étude
Statut
Inconnue
Les conditions
Description détaillée
All consecutive subjects coming to the 2 dedicated centers for COVID-19 screening in Clermont-Ferrand University hospital (one for medical students and one for the general population) will be asked to be included in the present study. They will be randomly assigned to either supervised self-swabbing followed by conventional swabbing led by a healthcare professional or the other way round.
All the subjects will have to complete a brief questionnaire including demographical characteristics (age, sex, height, weight, eye color), potential symptoms (asthenia, fever, anosmia…) anticipated pain and discomfort and previous nasopharyngeal swabbing experience. Pain, discomfort and overall acceptability of the procedure will be completed just after completion of the swabbing.
Type d'étude
Interventionnel
Inscription (Anticipé)
400
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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-
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Clermont-Ferrand, France, 63000
- CHU de Clermont-Ferrand
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Any subject coming for nasopharyngeal swabbing for SARS-CoV-2 screening
- Fluent in French (both oral and written)
- Able to give an eclaired consent
Exclusion Criteria:
- Contra-indication to nasopharyngeal swabbing
- Refusal to participate
- Pregnant women
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Supervised self-swabbing followed by conventional swabbing
the subjects will first benefit from a 5 minutes explanation on how to perform self-swabbing and will then performed the swabbing under the supervision of a trained healthcare professional
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Patient realises the nasal swabbing himself first, then undergoes conventionnal swabbing
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|
Expérimental: Conventional swabbing followed by supervised self-swabbing
the subject will undergo conventional nasopharyngeal swabbing performed by a trained healthcare professional first.
|
patient undergoes conventionnal swabbing first then realises the nasal swabbing himself
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Non-inferiority of self-swabbing compared to conventional swabbing concerning diagnosis sensitivity
Délai: 5 minutes after the end of the procedure of nasopharyngeal swabbing
|
assessed using consistency of COVID-19 RT-PCR results for both sampling modalities (Self- swabbing versus conventional-swabbing).
If non-inferiority is confirmed on this criterion, pain will be tested.
|
5 minutes after the end of the procedure of nasopharyngeal swabbing
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Correlation between age, sex and swabbing-induced pain
Délai: 5 minutes after the end of the procedure
|
Score on the pain numeric rating scale (0 to 10; higher scores meaning more pain)
|
5 minutes after the end of the procedure
|
|
Correlation between eye color and swabbing-induced pain
Délai: 5 minutes after the end of the procedure
|
Eye-color self-reported by the subject on a validated 14 item scale and pain score on the numeric rating scale (NRS) (0 to 10; higher scores meaning more pain)
|
5 minutes after the end of the procedure
|
|
Correlation between eye color and swabbing-induced discomfort
Délai: 5 minutes after the end of the procedure
|
Eye-color self-reported by the subject on a validated 14 item scale and discomfort score on numeric rating scale (0 to 10; higher scores meaning more discomfort)
|
5 minutes after the end of the procedure
|
|
Correlation between symptoms (fever, headache, asthenia, anosmia, agueusia, cough, dyspnea, muscle pain, sore throat, diarrhea) and swabbing-induced pain
Délai: 5 minutes after the end of the procedure
|
symptoms self-reported by the subject and pain score on numeric rating scale (0 to 10; higher scores meaning more pain)
|
5 minutes after the end of the procedure
|
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Correlation between body mass index and swabbing-induced pain
Délai: 5 minutes after the end of the procedure
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symptoms self-reported by the subject and pain score on numeric rating scale (0 to 10; higher scores meaning more pain)
|
5 minutes after the end of the procedure
|
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Correlation between anticipated pain and actual pain
Délai: 5 minutes after the end of the procedure
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anticipated and actual pain self-reported on numeric rating scale (0 to 10; higher scores meaning more pain)
|
5 minutes after the end of the procedure
|
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Correlation between anticipated discomfort and actual discomfort.
Délai: 5 minutes after the end of the procedure
|
anticipated and actual discomfort self-reported on numeric rating scale (0 to 10; higher scores meaning more pain)
|
5 minutes after the end of the procedure
|
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Richness assessment for respiratory cells
Délai: Day 0
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Ct value of beta-globin gene
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Day 0
|
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Non-inferiority of self-swabbing compared to conventional swabbing concerning pain
Délai: 5 minutes after the end of the procedure of nasopharyngeal swabbing
|
assessed using a Numerical Rating Scale (0 indicating no pain and 10 the worst imaginable pain).
If non-inferiority is confirmed on this criterion, discomfort will be tested
|
5 minutes after the end of the procedure of nasopharyngeal swabbing
|
|
Non-inferiority of self-swabbing compared to conventional swabbing concerning pain discomfort
Délai: 5 minutes after the end of the procedure of nasopharyngeal swabbing
|
assessed using a Numerical Rating Scale (0 indicating no discomfort and 10 the worst imaginable discomfort).
If non-inferiority is confirmed on this criterion, acceptability will be tested
|
5 minutes after the end of the procedure of nasopharyngeal swabbing
|
|
Non-inferiority of self-swabbing compared to conventional swabbing concerning acceptability
Délai: 5 minutes after the end of the procedure of nasopharyngeal swabbing
|
assessed using a Numerical Rating Scale (0 indicating that the procedure is not acceptable at all and 10 that the procedure is perfectly well accepted).
|
5 minutes after the end of the procedure of nasopharyngeal swabbing
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Xavier MOISSET, University Hospital, Clermont-Ferrand
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Anticipé)
1 avril 2021
Achèvement primaire (Anticipé)
1 octobre 2021
Achèvement de l'étude (Anticipé)
1 décembre 2021
Dates d'inscription aux études
Première soumission
1 avril 2021
Première soumission répondant aux critères de contrôle qualité
2 avril 2021
Première publication (Réel)
5 avril 2021
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
5 avril 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
2 avril 2021
Dernière vérification
1 mars 2021
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- RBHP 2020 MOISSET 2
- 2020-A02913-36 (Autre identifiant: ANSM)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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